Ulcerative Colitis Chronic ModeratePhase 1NCT05912712
Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum for the Topical Treatment of Rectal Mucosal Ulcers
A Phase 1 study testing Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum Treatment, Autologous Platelet-poor Plasma (PPP) and Thrombin Coagulum Treatment and Mesalazine Suppository Treatment in people with Ulcerative Colitis Chronic Moderate and Ulcerative Colitis Chronic Severe, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
Ulcerative colitis (UC) is a chronic persistent inflammatory disease. The lesions are mainly confined to the large intestine and continuously affect the rectum and part or all of the colon. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe, Rectal Ulcer
- What is being tested?
- Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum Treatment, Autologous Platelet-poor Plasma (PPP) and Thrombin Coagulum Treatment and Mesalazine Suppository Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Platelet ≥150×10^9g/L, hemoglobin ≥60g/L;
- Patients with ulcerative colitis were diagnosed according to the diagnostic criteria of ulcerative colitis in the 2018 China's National consensus on the diagnosis and treatment of inflammatory bowel disease;
- Patients with moderate to severe ulcerative colitis involving the rectum or refractory distal rectal ulcerative colitis (modified Mayo score ≥6 and endoscopic Mayo score ≥2);
- Patients with ulcerative colitis who were initially treated with infliximab (according to a regular intravenous infusion schedule of 0w, 2w, 6w, and then every 8w);
- Patients who were able and willing to adhere to the study protocol provided signed, dated, written informed consent.
Who cannot join
- Patients with platelet-related bleeding diseases (such as Henoch-Schonlein purpura, coagulopathy, primary/secondary thrombocytopenia, etc.);
- Medications with anticoagulant effects such as nonsteroidal anti-inflammatory drugs, heparin, coumarin, warfarin, aspirin, etc. (acetaminophen was used to treat discomfort during the study period);
- Patients using mesalazine enema solution during treatment;
- Patients with active infection of intestinal or other extra-intestinal organs (hepatitis, active tuberculosis, etc.);
- Patients with known hypersensitivity to calcium gluconate and thrombin
- Patients who may require immediate surgical treatment;
Show all 11Show fewer
- Pregnant or nursing mothers;
- Patients with severe liver and kidney dysfunction, heart failure or other serious systemic diseases;
- Any conditions that prevent the completion of the study or interfere with the analysis of the study results, including drug or alcohol abuse history, smoking abstinence, mental illness or poor compliance, and clear immune system (including HIV infection), blood system or cancer related diseases;
- Patients who withdraw consent;
- Patients enrolled in other clinical trials within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety And Efficacy Study of Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum for the Topical Treatment of Rectal Mucosal Ulcers
Ulcerative colitis (UC) is a chronic persistent inflammatory disease. The lesions are mainly confined to the large intestine and continuously affect the rectum and part or all of the colon. Its histological characteristics are diffuse neutrophil infiltration in the lamina propria of the colon mucosa, mucosal erosion, ulcer, cryptitis, and crypt abscess. The most common clinical manifestations are abdominal pain, diarrhea, and bloody mucopurulent stool, accompanied by extraintestinal manifestations such as mouth, skin, joints, and eyes. Severe lesions can be complicated by toxic megacolon, intestinal perforation, lower gastrointestinal hemorrhage, intraepithelial neoplasia, and cancer, so surgical treatment is necessary. Studies have reported that UC patients have a 10-year cumulative recurrence risk of 70%-80%, nearly 50% of patients require UC-related hospitalization, and the 5-year risk of re-hospitalization is ~ 50%. The 5-year and 10-year cumulative risk of patients undergoing colectomy is 10%-15%, which dramatically endangers the health of patients and reduces the quality of life of patients.
Currently, the commonly used medical treatment drugs for UC patients include 5-aminosalicylic acid, topical and systemic glucocorticoids, immunomodulators, anti-tumor necrosis factor drugs, and other biological agents. The most commonly used optimization methods are drug escalation therapy and combining drugs with different mechanisms. The real-world data results of an initial population-based cohort study from six Asian countries showed that the endoscopic mucosal healing rate of patients with ulcerative colitis in the first year of diagnosis was 38.2%, and the histological mucosal healing rate was 23.1%. It can be expected that the mucosal healing rate of patients with moderate to severe UC may be lower. Long-term chronic recurrent diseases may lead to poorer quality of life, extended hospital stays, heavier financial burdens, and more physical and mental pain. Therefore, optimizing the treatment plan for patients with moderate to severe UC needs more exploration and research.
Read more
Autologous Platelet-rich plasma (A-PRP) is A platelet-rich concentrate obtained by centrifugation of whole blood. As a concentrated source of autologous platelets, they contain a large number of Growth factors (GF) and cytokines, such as platelet-derived Growth factor (PDGF), transforming growth factor β(TGF-β), vascular endothelial growth factor (VEGF) and epithelial growth factor (EGF), which regulate cell function. Such as attachment, macrophage migration, proliferation, and differentiation, promote extracellular matrix accumulation and ultimately improve tissue healing and regeneration. At the same time, A-PRP has A lower risk of adverse reactions such as immune rejection and allergy due to its isolation from autologous blood.
After PRP is induced by activators such as calcium and thrombin, activated platelets degranulate immediately and secrete multiple high concentrations of growth factors. 70% of the growth factors can be released within 10 minutes of activation, and more than 95% can be released within the first hour. Platelet-rich Gel (PG), which can embed growth factors to improve clinical efficacy, keeps platelets and their release products in the target wound area and promotes healing.
Although the safety and efficacy of PRP still need to be fully confirmed by large-scale clinical trials, its sound effect has been verified in many clinical practices and basic scientific research in cell culture and animal models. At present, it mainly includes the treatment of oral and maxillofacial external, musculoskeletal system, plastic skin, and chronic wounds (such as pressure ulcers, venous leg ulcers, diabetic foot ulcers, etc.). They can be mixed into bone grafts, sprayed on soft tissue surfaces as a biofilm, or made into eye drops.
The use of PRP in intestinal mucosal ulcers has rarely been reported. There are no prospective randomized studies of its clinical use in patients with ulcerative colitis. Therefore, we planned to conduct a prospective, randomized, double-blind, controlled clinical trial to investigate the efficacy and safety of repeated treatment with autologous platelet-rich plasma gel on an intestinal mucosal ulcer in patients with moderate to severe UC involving the rectum in Xijing Hospital, China IBD Regional Center. To provide a new option for remission induction therapy in patients with moderate to severe ulcerative colitis.
- Being tested
- Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum Treatment, Autologous Platelet-poor Plasma (PPP) and Thrombin Coagulum Treatment, Mesalazine Suppository Treatment, Infliximab Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum TreatmentOther
10 mL PRP and thrombin coagulum gel was administered every night for seven consecutive days by the same IBD specialist. Before the intervention, the patients had to defecate. The prepared PRP gel was injected into the external opening of the rectum using the same syringe, and the patient was kept in the Trendelenburg position to ensure that the therapeutic drug remained in place under gravity. The normal supine position was returned after 15 minutes to minimize PRP leakage. The outflow was observed, and the amount of outflow was recorded.
Autologous Platelet-poor Plasma (PPP) and Thrombin Coagulum TreatmentOther
10 mL PPP and thrombin coagulum gel was administered every night for seven consecutive days by the same IBD specialist. Before the intervention, the patients had to defecate. The prepared PPP gel was injected into the external opening of the rectum using the same syringe, and the patient was kept in the Trendelenburg position to ensure that the therapeutic drug remained in place under gravity. The normal supine position was returned after 15 minutes to minimize PPP leakage. The outflow was observed, and the amount of outflow was recorded.
Mesalazine Suppository TreatmentDrug
For patients receiving mesalazine suppositories, the intervention was inserted through the anus with a disposable sanitary finger to the point of slight loss of resistance. To facilitate intervention, moisturize with water or cream. If the drug drains within 10 minutes, it should be re-inserted. The swelling at the local injection site on each group's intervention day was recorded.
Infliximab TreatmentBiological
Patients, in every arm, all receive infliximab (300 mg iv at 0, 2, 6 weeks, and then every eight weeks).
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich Plasma (PRP) Gel Treatment Group | Experimental | Rectal 10ml platelet rich plasma gel enema + infliximab standard treatment at fixed time every day for seven consecutive days Receives: Other: Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum Treatment; Biological: Infliximab Treatment |
| Platelet Poor Plasma (PPP) Gel Treatment Group | Sham comparator | Rectal 10ml PPP gel enema + infliximab standard treatment for 7 consecutive days Receives: Other: Autologous Platelet-poor Plasma (PPP) and Thrombin Coagulum Treatment; Biological: Infliximab Treatment |
| Mesalazine Suppository Treatment Group | Active comparator | Patients were given 1g mesalazine suppository and infliximab daily for 7 consecutive days Receives: Drug: Mesalazine Suppository Treatment; Biological: Infliximab Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic response rate of local treatment with autologous platelet-rich plasma gel
Endoscopic response rate of local treatment with autologous platelet-rich plasma gel in patients with moderate to severe ulcerative colitis involving the rectum.
Measured: 14 weeks
Secondary outcomes (6)
Endoscopic remission rate of local treatment with autologous platelet-rich plasma gel
Endoscopic remission rate of local treatment with autologous platelet-rich plasma gel in patients with moderate to severe ulcerative colitis involving the rectum.
Measured: 1 week and 14 weeks
Clinical response rate of PRP-thrombin coagulum treatment on Rectal Mucosal Ulcers
The clinical response rate will be analyzed.
Measured: 1 week and 14 weeks
Clinical remission rate of PRP-thrombin coagulum treatment on Rectal Mucosal Ulcers
The clinical remission rate will be analyzed.
Measured: 1 week and 14 weeks
Inflammatory parameter alteration with PRP-thrombin coagulum treatment on Rectal Mucosal Ulcers
The erythrocyte sedimentation rate will be analyzed.
Measured: 1 week, 2 weeks, 6 weeks, and 14 weeks
Inflammatory response alteration with PRP-thrombin coagulum treatment on Rectal Mucosal Ulcers
The C-reactive protein concentration will be analyzed.
Measured: 1 week, 2 weeks, 6 weeks, and 14 weeks
Incidence of Adverse Events
Adverse events will reported at the start and throughout the treatment period.
Measured: 1 week, 2 weeks, 6 weeks, and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis Chronic ModerateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Liang, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912712
- Sponsor's protocol ID
- XijingHDD-UC-PG
- Status last verified
- Jun 2023
- First submitted
- 15 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fumery M, Singh S, Dulai PS, Gower-Rousseau C, Peyrin-Biroulet L, Sandborn WJ. Natural History of Adult Ulcerative Colitis in Population-based Cohorts: A Systematic Review. Clin Gastroenterol Hepatol. 2018 Mar;16(3):343-356.e3. doi: 10.1016/j.cgh.2017.06.016. Epub 2017 Jun 16.
PubMed 28625817Leung CM, Tang W, Kyaw M, Niamul G, Aniwan S, Limsrivilai J, Wang YF, Ouyang Q, Simadibrata M, Abdullah M, Ong DE, Yu HH, Zhang J, Ching J, Wu JCY, Chan FKL, Sung JJY, Ng SC. Endoscopic and Histological Mucosal Healing in Ulcerative Colitis in the First Year of Diagnosis: Results from a Population-based Inception Cohort from Six Countries in Asia. J Crohns Colitis. 2017 Dec 4;11(12):1440-1448. doi: 10.1093/ecco-jcc/jjx103.
PubMed 28961760Lee JW, Kwon OH, Kim TK, Cho YK, Choi KY, Chung HY, Cho BC, Yang JD, Shin JH. Platelet-rich plasma: quantitative assessment of growth factor levels and comparative analysis of activated and inactivated groups. Arch Plast Surg. 2013 Sep;40(5):530-5. doi: 10.5999/aps.2013.40.5.530. Epub 2013 Sep 13.
PubMed 24086805Lee JH, Kim MJ, Ha SW, Kim HK. Autologous Platelet-rich Plasma Eye Drops in the Treatment of Recurrent Corneal Erosions. Korean J Ophthalmol. 2016 Apr;30(2):101-7. doi: 10.3341/kjo.2016.30.2.101. Epub 2016 Mar 25.
PubMed 27051257Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
PubMed 15085519Nikolidakis D, Jansen JA. The biology of platelet-rich plasma and its application in oral surgery: literature review. Tissue Eng Part B Rev. 2008 Sep;14(3):249-58. doi: 10.1089/ten.teb.2008.0062.
PubMed 18601587Al-Hamed FS, Abu-Nada L, Rodan R, Sarrigiannidis S, Ramirez-Garcialuna JL, Moussa H, Elkashty O, Gao Q, Basiri T, Baca L, Torres J, Rancan L, Tran SD, Lordkipanidze M, Kaartinen M, Badran Z, Tamimi F. Differences in platelet-rich plasma composition influence bone healing. J Clin Periodontol. 2021 Dec;48(12):1613-1623. doi: 10.1111/jcpe.13546. Epub 2021 Sep 27.
PubMed 34517437Hesseler MJ, Shyam N. Platelet-rich plasma and its utility in medical dermatology: A systematic review. J Am Acad Dermatol. 2019 Sep;81(3):834-846. doi: 10.1016/j.jaad.2019.04.037. Epub 2019 Apr 19.
PubMed 31009668Shao S, Pan R, Chen Y. Autologous Platelet-Rich Plasma for Diabetic Foot Ulcer. Trends Endocrinol Metab. 2020 Dec;31(12):885-890. doi: 10.1016/j.tem.2020.10.003. Epub 2020 Nov 13.
PubMed 33199085
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Efficacy Study of Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum for the Topical Treatment of Rectal Mucosal Ulcers
- ClinicalTrials.gov ID
- NCT05912712
- Acronym / sponsor ID
- XijingHDD-UC-PG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ulcerative colitis (UC) is a chronic persistent inflammatory disease. The lesions are mainly confined to the large intestine and continuously affect the rectum and part or all of the colon. Its histological characteristics are diffuse neutrophil infiltration in the lamina propria of the colon mucosa, mucosal erosion, ulcer, cryptitis, and crypt abscess. The most common clinical manifestations are abdominal pain, diarrhea, and bloody mucopurulent stool, accompanied by extraintestinal manifestations such as mouth, skin, joints, and eyes. Severe lesions can be complicated by toxic megacolon, intestinal perforation, lower gastrointestinal hemorrhage, intraepithelial neoplasia, and cancer, so surgical treatment is necessary. Studies have reported that UC patients have a 10-year cumulative recurrence risk of 70%-80%, nearly 50% of patients require UC-related hospitalization, and the 5-year risk of re-hospitalization is ~ 50%. The 5-year and 10-year cumulative risk of patients undergoing colectomy is 10%-15%, which dramatically endangers the health of patients and reduces the quality of life of patients.
Currently, the commonly used medical treatment drugs for UC patients include 5-aminosalicylic acid, topical and systemic glucocorticoids, immunomodulators, anti-tumor necrosis factor drugs, and other biological agents. The most commonly used optimization methods are drug escalation therapy and combining drugs with different mechanisms. The real-world data results of an initial population-based cohort study from six Asian countries showed that the endoscopic mucosal healing rate of patients with ulcerative colitis in the first year of diagnosis was 38.2%, and the histological mucosal healing rate was 23.1%. It can be expected that the mucosal healing rate of patients with moderate to severe UC may be lower. Long-term chronic recurrent diseases may lead to poorer quality of life, extended hospital stays, heavier financial burdens, and more physical and mental pain. Therefore, optimizing the treatment plan for patients with moderate to severe UC needs more exploration and research.
Autologous Platelet-rich plasma (A-PRP) is A platelet-rich concentrate obtained by centrifugation of whole blood. As a concentrated source of autologous platelets, they contain a large number of Growth factors (GF) and cytokines, such as platelet-derived Growth factor (PDGF), transforming growth factor β(TGF-β), vascular endothelial growth factor (VEGF) and epithelial growth factor (EGF), which regulate cell function. Such as attachment, macrophage migration, proliferation, and differentiation, promote extracellular matrix accumulation and ultimately improve tissue healing and regeneration. At the same time, A-PRP has A lower risk of adverse reactions such as immune rejection and allergy due to its isolation from autologous blood.
After PRP is induced by activators such as calcium and thrombin, activated platelets degranulate immediately and secrete multiple high concentrations of growth factors. 70% of the growth factors can be released within 10 minutes of activation, and more than 95% can be released within the first hour. Platelet-rich Gel (PG), which can embed growth factors to improve clinical efficacy, keeps platelets and their release products in the target wound area and promotes healing.
Although the safety and efficacy of PRP still need to be fully confirmed by large-scale clinical trials, its sound effect has been verified in many clinical practices and basic scientific research in cell culture and animal models. At present, it mainly includes the treatment of oral and maxillofacial external, musculoskeletal system, plastic skin, and chronic wounds (such as pressure ulcers, venous leg ulcers, diabetic foot ulcers, etc.). They can be mixed into bone grafts, sprayed on soft tissue surfaces as a biofilm, or made into eye drops.
The use of PRP in intestinal mucosal ulcers has rarely been reported. There are no prospective randomized studies of its clinical use in patients with ulcerative colitis. Therefore, we planned to conduct a prospective, randomized, double-blind, controlled clinical trial to investigate the efficacy and safety of repeated treatment with autologous platelet-rich plasma gel on an intestinal mucosal ulcer in patients with moderate to severe UC involving the rectum in Xijing Hospital, China IBD Regional Center. To provide a new option for remission induction therapy in patients with moderate to severe ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich Plasma (PRP) Gel Treatment Group | Experimental | Other: Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum Treatment, Biological: Infliximab TreatmentRectal 10ml platelet rich plasma gel enema + infliximab standard treatment at fixed time every day for seven consecutive days |
| Platelet Poor Plasma (PPP) Gel Treatment Group | Sham comparator | Other: Autologous Platelet-poor Plasma (PPP) and Thrombin Coagulum Treatment, Biological: Infliximab TreatmentRectal 10ml PPP gel enema + infliximab standard treatment for 7 consecutive days |
| Mesalazine Suppository Treatment Group | Active comparator | Drug: Mesalazine Suppository Treatment, Biological: Infliximab TreatmentPatients were given 1g mesalazine suppository and infliximab daily for 7 consecutive days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Platelet ≥150×10^9g/L, hemoglobin ≥60g/L;
- Patients with ulcerative colitis were diagnosed according to the diagnostic criteria of ulcerative colitis in the 2018 China's National consensus on the diagnosis and treatment of inflammatory bowel disease;
- Patients with moderate to severe ulcerative colitis involving the rectum or refractory distal rectal ulcerative colitis (modified Mayo score ≥6 and endoscopic Mayo score ≥2);
- Patients with ulcerative colitis who were initially treated with infliximab (according to a regular intravenous infusion schedule of 0w, 2w, 6w, and then every 8w);
- Patients who were able and willing to adhere to the study protocol provided signed, dated, written informed consent.
Key exclusion criteria (11 listed)
- Patients with platelet-related bleeding diseases (such as Henoch-Schonlein purpura, coagulopathy, primary/secondary thrombocytopenia, etc.);
- Medications with anticoagulant effects such as nonsteroidal anti-inflammatory drugs, heparin, coumarin, warfarin, aspirin, etc. (acetaminophen was used to treat discomfort during the study period);
- Patients using mesalazine enema solution during treatment;
- Patients with active infection of intestinal or other extra-intestinal organs (hepatitis, active tuberculosis, etc.);
- Patients with known hypersensitivity to calcium gluconate and thrombin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum Treatment10 mL PRP and thrombin coagulum gel was administered every night for seven consecutive days by the same IBD specialist. Before the intervention, the patients had to defecate. The prepared PRP gel was injected into the external opening of the rectum using the same syringe, and the patient was kept in the Trendelenburg position to ensure that the therapeutic drug remained in place under gravity. The normal supine position was returned after 15 minutes to minimize PRP leakage. The outflow was observed, and the amount of outflow was recorded. | Other | Platelet-rich Plasma (PRP) Gel Treatment Group |
| Autologous Platelet-poor Plasma (PPP) and Thrombin Coagulum Treatment10 mL PPP and thrombin coagulum gel was administered every night for seven consecutive days by the same IBD specialist. Before the intervention, the patients had to defecate. The prepared PPP gel was injected into the external opening of the rectum using the same syringe, and the patient was kept in the Trendelenburg position to ensure that the therapeutic drug remained in place under gravity. The normal supine position was returned after 15 minutes to minimize PPP leakage. The outflow was observed, and the amount of outflow was recorded. | Other | Platelet Poor Plasma (PPP) Gel Treatment Group |
| Mesalazine Suppository TreatmentFor patients receiving mesalazine suppositories, the intervention was inserted through the anus with a disposable sanitary finger to the point of slight loss of resistance. To facilitate intervention, moisturize with water or cream. If the drug drains within 10 minutes, it should be re-inserted. The swelling at the local injection site on each group's intervention day was recorded. | Drug | Mesalazine Suppository Treatment Group |
| Infliximab TreatmentPatients, in every arm, all receive infliximab (300 mg iv at 0, 2, 6 weeks, and then every eight weeks). | Biological | Mesalazine Suppository Treatment Group, Platelet Poor Plasma (PPP) Gel Treatment Group, Platelet-rich Plasma (PRP) Gel Treatment Group |
Primary outcome
Endoscopic response rate of local treatment with autologous platelet-rich plasma gel
Time frame: 14 weeks
Endoscopic response rate of local treatment with autologous platelet-rich plasma gel in patients with moderate to severe ulcerative colitis involving the rectum.
6 secondary outcomes
Endoscopic remission rate of local treatment with autologous platelet-rich plasma gel
Time frame: 1 week and 14 weeks
Clinical response rate of PRP-thrombin coagulum treatment on Rectal Mucosal Ulcers
Time frame: 1 week and 14 weeks
Clinical remission rate of PRP-thrombin coagulum treatment on Rectal Mucosal Ulcers
Time frame: 1 week and 14 weeks
Inflammatory parameter alteration with PRP-thrombin coagulum treatment on Rectal Mucosal Ulcers
Time frame: 1 week, 2 weeks, 6 weeks, and 14 weeks
Inflammatory response alteration with PRP-thrombin coagulum treatment on Rectal Mucosal Ulcers
Time frame: 1 week, 2 weeks, 6 weeks, and 14 weeks
Incidence of Adverse Events
Time frame: 1 week, 2 weeks, 6 weeks, and 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 28625817Fumery M, Singh S, Dulai PS, Gower-Rousseau C, Peyrin-Biroulet L, Sandborn WJ. Natural History of Adult Ulcerative Colitis in Population-based Cohorts: A Systematic Review. Clin Gastroenterol Hepatol. 2018 Mar;16(3):343-356.e3. doi: 10.1016/j.cgh.2017.06.016. Epub 2017 Jun 16.
- Background: PubMed 28961760Leung CM, Tang W, Kyaw M, Niamul G, Aniwan S, Limsrivilai J, Wang YF, Ouyang Q, Simadibrata M, Abdullah M, Ong DE, Yu HH, Zhang J, Ching J, Wu JCY, Chan FKL, Sung JJY, Ng SC. Endoscopic and Histological Mucosal Healing in Ulcerative Colitis in the First Year of Diagnosis: Results from a Population-based Inception Cohort from Six Countries in Asia. J Crohns Colitis. 2017 Dec 4;11(12):1440-1448. doi: 10.1093/ecco-jcc/jjx103.
- Background: PubMed 24086805Lee JW, Kwon OH, Kim TK, Cho YK, Choi KY, Chung HY, Cho BC, Yang JD, Shin JH. Platelet-rich plasma: quantitative assessment of growth factor levels and comparative analysis of activated and inactivated groups. Arch Plast Surg. 2013 Sep;40(5):530-5. doi: 10.5999/aps.2013.40.5.530. Epub 2013 Sep 13.
- Background: PubMed 27051257Lee JH, Kim MJ, Ha SW, Kim HK. Autologous Platelet-rich Plasma Eye Drops in the Treatment of Recurrent Corneal Erosions. Korean J Ophthalmol. 2016 Apr;30(2):101-7. doi: 10.3341/kjo.2016.30.2.101. Epub 2016 Mar 25.
- Background: PubMed 15085519Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
- Background: PubMed 18601587Nikolidakis D, Jansen JA. The biology of platelet-rich plasma and its application in oral surgery: literature review. Tissue Eng Part B Rev. 2008 Sep;14(3):249-58. doi: 10.1089/ten.teb.2008.0062.
- Background: PubMed 34517437Al-Hamed FS, Abu-Nada L, Rodan R, Sarrigiannidis S, Ramirez-Garcialuna JL, Moussa H, Elkashty O, Gao Q, Basiri T, Baca L, Torres J, Rancan L, Tran SD, Lordkipanidze M, Kaartinen M, Badran Z, Tamimi F. Differences in platelet-rich plasma composition influence bone healing. J Clin Periodontol. 2021 Dec;48(12):1613-1623. doi: 10.1111/jcpe.13546. Epub 2021 Sep 27.
- Background: PubMed 31009668Hesseler MJ, Shyam N. Platelet-rich plasma and its utility in medical dermatology: A systematic review. J Am Acad Dermatol. 2019 Sep;81(3):834-846. doi: 10.1016/j.jaad.2019.04.037. Epub 2019 Apr 19.
- Background: PubMed 33199085Shao S, Pan R, Chen Y. Autologous Platelet-Rich Plasma for Diabetic Foot Ulcer. Trends Endocrinol Metab. 2020 Dec;31(12):885-890. doi: 10.1016/j.tem.2020.10.003. Epub 2020 Nov 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum Treatment, Autologous Platelet-poor Plasma (PPP) and Thrombin Coagulum Treatment and Mesalazine Suppository Treatment in people with Ulcerative Colitis Chronic Moderate and Ulcerative Colitis Chronic Severe, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanting Shi, M.S. (+86-029-84771535, yantings@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic response rate of local treatment with autologous platelet-rich plasma gel (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05912712, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.